MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1416

Device Problems Unexpected Therapeutic Results (1631); Battery Problem (2885)

Patient Problem Shaking/Tremors (2515)

Event Date 07/25/2023

Event Type  Injury  

Event Description

It was reported that the patients deep brain stimulation (dbs) implantable pulse generator (ipg) reached end of battery life (eobl) soon after receiving the elective removal indicator (eri) message.It was noted that electrocautery was used during a lead revision procedure performed (b)(6) 2023.The patient underwent a procedure where the ipg was replaced with a rechargeable device.The patient did well post-operatively.

Manufacturer Narrative

The returned implantable pulse generator (ipg) was analyzed and revealed normal characteristics during visual inspection.However, a memory download revealed the log partially corrupted.Additionally, electrical testing revealed a high sleep current 7.1ma and low vh resistance measurement of 8.3 kilo-ohms indicative of exposure to high voltage sources causing an electrical short within the application specific integrated circuit (asic).A product labeling review identified that the device was used per the instructions for use (ifu), product label.Additionally, the ifu states that failure of malfunction of any device components or the battery including electrical shorts caused by electrocautery.Based on all the available information, engineers confirmed exposure to electrocautery can cause this damage and concluded that unintended use error caused of contributed to the event.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19111602
• MDR Text Key: 340223954
• Report Number: 3006630150-2023-08644
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985020
• UDI-Public: 08714729985020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2023
• Device Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 202847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: White